Trial · NCT07072585
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free survival (EFS) in patients with newly diagnosed T-cell lymphoblastic leukemia (T-ALL) | From date of randomization (randomization conducted at the end of induction [EOI]) to date of first event (consolidation failure, interim maintenance failure, relapse, secondary malignant neoplasm [SMN], death from any cause), assessed up to 4 years | Will compare EFS in patients with newly diagnosed T-ALL who are randomized to either receive a modified augmented Berlin-Frankfurt-Munich (aBFM) chemotherapy backbone or a modified aBFM backbone with the addition of daratumumab. Patients without an EFS event will be censored at the date of last follow-up. The survival time analyses assume a Weibull distribution with a shape parameter of 0.45 (based on historical controls). A phase 2/3 design will be used. |
| Primary | EFS in patients with newly diagnosed T-cell lymphoblastic lymphoma (T-LL) | From date of randomization (randomization conducted at the EOI) to date of first event (consolidation failure, relapse, progressive disease, SMN, death from any cause), assessed up to 4 years | Will compare EFS in patients with newly diagnosed T-LL who are randomized to a modified aBFM chemotherapy backbone with bortezomib or to a modified aBFM backbone with bortezomib and the addition of daratumumab. Patients without an EFS event will be censored at the date of last follow-up. The survival time analyses assume a Weibull distribution with a shape parameter of 0.45 (based on historical controls). |
| Secondary | Health-related quality of life (HRQoL) | Baseline (at time of randomization) to day 64 of consolidation | Will compare HRQoL between patients with T-ALL or T-LL randomized to a modified aBFM backbone or to a modified aBFM backbone with the addition of daratumumab. Will use the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health scale (PGH-7). The PROMIS PGH-7 has a standard deviation of 10 points, with higher scores indicating better HRQoL. |
| Secondary | Incidence of therapy-related toxicity and tolerability | Assessed up to 3 cycles post randomization (each cycle is approximately 2-3 months) | Will compare therapy-related toxicity and tolerability between patients with T-ALL or T-LL randomized to a modified aBFM backbone or to a modified aBFM backbone with the addition of daratumumab. Will be assessed for all patients and the rates compared between the randomized arms (T-ALL: arm A versus (vs) arm B and T-LL: arm C vs arm D). Rates by arm will be reviewed by the study committee on a monthly basis and will also be provided in the biannual reports to the Children's Oncology Group Data and Safety Monitoring Committee for review. Any concerns regarding excessive rates of any toxicities will be discussed in the context of any required therapy modifications. |
| Secondary | Overall survival (OS) in patients with newly diagnosed T-ALL | From date of randomization (randomization conducted at the EOI) to date of death (death due to any cause), assessed up to 4 years | Will compare OS in patients with newly diagnosed T-ALL who are randomized to either receive a modified aBFM chemotherapy backbone or a modified aBFM backbone with the addition of daratumumab. Patients who are alive will be censored at date of last follow-up. Comparison of OS between the two randomized arms will be conducted at the time of the final analysis for the primary objective (EFS). Analyses will be based on stratified log-rank tests. In addition, descriptive OS rates post randomization will be estimated using the Kaplan-Meier method and standard errors and confidence intervals estimated by the method of Peto. In particular, 4-year OS rates in arm A and arm B will be estimated. Estimation of treatment effect will be done using intent-to-treat (ITT) analysis. Hazard ratio (HR) and the confidence interval will be estimated based on Cox regression models as appropriate. |
| Secondary | Overall survival (OS) in patients with newly diagnosed T-LL | From date of randomization (randomization conducted at the EOI) to date of death (death due to any cause), assessed up to 4 years | Will compare OS in patients with newly diagnosed T-LL who are randomized to a modified aBFM chemotherapy backbone with bortezomib or to a modified aBFM backbone with bortezomib and the addition of daratumumab. Patients who are alive will be censored at date of last follow-up. Comparison of OS between the two randomized arms will be conducted at the time of the final analysis for the primary objective (EFS). Analyses will be based on log-rank tests. In addition, descriptive OS rates post randomization will be estimated using the Kaplan-Meier method and standard errors and confidence intervals estimated by the method of Peto. In particular, 4-year OS rates in arm C and arm D will be estimated. Estimation of treatment effect will be done using ITT analysis. HR and the confidence interval will be estimated based on Cox regression models as appropriate. |
| Other | EFS from end of induction patients with newly diagnosed T-LL | Assessed up to 4 years | Will determine if minumal residual disease (MRD) testing in patients with newly diagnosed T-LL at EOI can predict EFS. EFS will be compared for T-LL patients with negative MRD (defined as \< 0.1%) and those who with MRD ≥ 0.1% at the EOI. EFS will be defined as time from the EOI to date of first event (consolidation failure, relapse, progressive disease, SMN, death from any cause), and patients without an EFS event will be censored at the date of last follow-up. In addition, comparison of EFS by the EOI MRD status (positive vs negative) will be conducted among randomized patients. Comparisons will be conducted by treatment arms. A potential interaction between MRD at the EOI with treatment arms will be assessed. |
| Other | OS from end of Induction in patients with newly diagnosed T-LL | Assessed up to 4 years | Will determine if MRD testing in patients with newly diagnosed T-LL at EOI can predict OS. OS will be compared for T-LL patients with negative MRD (defined as \< 0.1%) and those who with MRD ≥ 0.1% at the EOI. OS will be defined as time from the EOI to date of death, with patients who are alive being censored at date of last follow-up. In addition, comparison of OS by the EOI MRD status (positive vs negative) will be conducted among randomized patients. Comparisons will be conducted by treatment arms. A potential interaction between MRD at the EOI with treatment arms will be assessed. |
| Other | Immunophenotype in T-ALL patients | Assessed at baseline, end of Induction (Induction is 29 days), and relapse (up to 10 years) | Will describe changes in T-ALL patients in the immunophenotype (specifically CD38 surface expression on T-ALL/T-LL blasts) correlate changes with clinical outcomes and demographic variables. Differences between patients treated with daratumumab and those who are not treated with daratumumab will be assessed; the comparisons between arm A and arm B will be based on test of proportions, Fisher's exact test or logistic regression, as appropriate. |
| Other | Development of anti-daratumumab antibodies in T-ALL patients | Assessed up to 3 years | Will describe the development of anti-daratumumab antibodies over the course of treatment and correlate changes with clinical outcomes and demographic variables. Analyses will be restricted to T-ALL patients randomized to arm B. Analyses will be based on test of proportions, Fisher exact test, logistic regression, log-rank test, semi-parametric or parametric survival analysis, as appropriate. |
| Other | Family-reported social determinants of health | Up to approximately 1 year of treatment | Will describe family-reported social determinants of health and assess its association with clinical outcomes (including incidence of treatment-related toxicities, EFS, OS), and leukemia/lymphoma and host biology. These analyses will be based on analysis of variance, test of proportions, logistic regression, log-rank test, semi-parametric or parametric survival analysis methods, etc., as appropriate. |
| Other | EFS from date of PET scan at the end of induction in patients with T-LL | Assessed up to 4 years | Will describe outcome differences (EFS) in patients with T-LL who differ in degrees of positron emission tomography (PET)-imaging avid disease at the EOI. EFS will be compared for T-LL patients with a positive PET scan (Deauville 4 and 5) to patients with a negative PET scan (Deauville 1, 2 and 3) at the EOI. EFS will be defined as time from date of PET scan (i.e., EOI) to date of first event (relapse, consolidation failure, progressive disease, SMN, death from any cause); patients without an EFS event will be censored at the date of last follow-up. EFS will be presented based on Kaplan-Meier method. Comparisons of EFS between PET positive and PET negative groups will be performed using log-rank test, semi-parametric or parametric survival analysis methods, as appropriate. |
| Other | OS from date of PET scan at the end of Induction in patients with newly diagnosed T-LL | Assessed up to 4 years | Will describe outcome differences (OS) in patients with T-LL who differ in degrees of PET-imaging avid disease at the EOI. OS will be compared for T-LL patients with a positive PET scan (Deauville 4 and 5) to patients with a negative PET scan (Deauville 1, 2 and 3) at the EOI. OS will be defined as time from date of PET scan to date of death, with patients who are alive censored at the date of last follow-up. OS curves will be presented based on Kaplan-Meier method. Comparisons of EFS/OS between PET positive and PET negative groups will be performed using log-rank test, semi-parametric or parametric survival analysis methods, as appropriate. |
| Other | Magnetic resonance imaging (MRI) imaging findings associated with onset of seizure or grade 3 or higher neurotoxicity attributed to treatment with nelarabine | Assessed to the end of protocol therapy, up to 3 years. | Will explore potential MRI imaging findings that are associated with severe nelarabine-induced central nervous system toxicities. In T-ALL patients that experience any new onset seizure or grade 3 or higher neurotoxicity attributed to treatment with nelarabine, results of MRI imaging and other biomarkers associated with toxicity and associations with clinical features will be described to determine potential risk factors. These analyses will be based on analysis of variance, test of proportions, log-rank test, semi-parametric or parametric survival analysis methods, etc., as appropriate. MRI findings will be analyzed to identify a pathognomonic signal of nelarabine neurotoxicity. In addition it is anticipated that MRIs obtained for this purpose will have signals which will exclude neurotoxic events related to non-nelarabine therapeutics. |
| Other | Peripheral blood specimens in patients with T-LL | Up to 10 years | Will bank peripheral blood specimens for future correlative studies in patients with T-LL. |
| Other | EFS from end of induction in patients with newly diagnosed T-ALL | Assessed up to 4 years | Will compare EFS from the EOI in patients with newly diagnosed T-ALL who are MRD positive (≥ 0.01%) at the EOI to those who are MRD negative at the EOI. EFS will be defined as time from the EOI to date of first event (consolidation failure, interim maintenance failure, relapse, SMN, death from any cause), and patients without an EFS event will be censored at the date of last follow-up. In addition, comparison of EFS by the EOI MRD status (positive vs negative) will be conducted among randomized patients (n=874, all of them should have the EOI MRD tested). For this comparison, EFS will be defined as time from date of randomization to date of first event (consolidation failure, interim maintenance failure, relapse, SMN, death from any cause), and patients without an EFS event will be censored at the date of last follow-up. |
| Other | OS from end of Induction in patients with newly diagnosed T-ALL | Assessed up to 4 years | Will compare OS from the EOI in patients with newly diagnosed T-ALL who are MRD positive (≥ 0.01%) at the EOI to those who are MRD negative at the EOI. OS will be defined as time from the EOI to date of death, with patients who are alive being censored at date of last follow-up. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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